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Kura Oncology, Inc.
Boston, MA, United States
Are you ready to join a team committed to making a meaningful impact on cancer treatment through the discovery and development of precision medicines? At Kura Oncology, you have an opportunity to be a part of something bigger, with a lasting impact that you can be proud of. At Kura Oncology, we are working to change the paradigm and improve the sci
Job Source: Kura Oncology, Inc.Kura Oncology, Inc.
Boston, MA, United States
Are you ready to join a team committed to making a meaningful impact on cancer treatment through the discovery and development of precision medicines? At Kura Oncology, you have an opportunity to be a part of something bigger, with a lasting impact that you can be proud of. At Kura Oncology, we are working to change the paradigm and improve the sc
Job Source: Kura Oncology, Inc.BioNTech IMFS
Cambridge, MA, United States
Press Tab to Move to Skip to Content Link Select how often (in days) to receive an alert: Associate Director Clinical Pharmacology Open for hire at one of the following locations – Cambridge Erie Street. - Job ID: 7319 Join our team of pioneers! As a part of our team of more than 5.000 pioneers, you will play a key role in developing solutions fo
Job Source: BioNTech IMFSBicycle Therapeutics Limited
Cambridge, MA, United States
Company Description Bicycle Therapeutics (NASDAQ: BCYC) is a clinical-stage biopharmaceutical company developing a novel class of medicines. Our pipeline includes Bicycle Toxin Conjugates as well as fully synthetic Bicycle systemic immune cell agonists and Bicycle tumor-targeted immune cell agonists (Bicycle TICAs) focused on oncology indications w
Job Source: Bicycle Therapeutics LimitedInvenia Group
Boston, MA, United States
Invenia Group is partnered with an exciting AI-powered clinical-stage biotech company, headquartered in the US, which is seeking an Associate Director of Clinical Pharmacology to oversee and lead the clinical pharmacology team. This position requires a strong scientific background, exceptional leadership skills, and a thorough understanding of the
Job Source: Invenia GroupAbbVie
Cambridge, MA, United States
Company Description AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas immunology, oncology, neuroscience, and eye care and products and serv
Job Source: AbbVieRegeneron Pharmaceuticals
Boston
We are looking for an Associate Director, within our Clinical Pharmacology group. Providing strategic and scientific expertise, as well as representing Clinical Pharmacology at relevant meetings. This position will provide CP subject matter support to new and on-going clinical programs primarily in the Oncology area. **This role must be onsite a mi
Job Source: Regeneron PharmaceuticalsRegeneron Pharmaceuticals
Boston, MA, United States
We are looking for an Associate Director, within our Clinical Pharmacology group. Providing strategic and scientific expertise, as well as representing Clinical Pharmacology at relevant meetings. This position will provide CP subject matter support to new and on-going clinical programs primarily in the Oncology area. This role must be onsite a mini
Job Source: Regeneron PharmaceuticalsBoston, MA, United States
Essential Job Functions
The Associate Director/Director of Clinical Pharmacology will be responsible for developing, driving, and implementing nonclinical and clinical ADME strategies. You will be a core member of program teams providing ADME perspectives and delivering modeling and analyses necessary to evaluate nonclinical and clinical options, enable plans, and optimize development programs. This includes gap analysis, study design, PKPD analysis and modeling, program assessment, and collaborations to help execute programs. The successful candidate will bring extensive experience in nonclinical and clinical ADME with the ability to work cross-functionally with multifunctional teams to drive programs to success.
Provides clinical pharmacology leadership on multi-disciplinary teams for oncology programs including modeling & simulation to satisfy world-wide regulatory requirements.
Provides clinical and nonclinical pharmacokinetic expertise to projects including study design, data analysis and interpretation.
Develop population PK, exposure-response, mechanistic PK/PD, PBPK and QSP models, as needed, to evaluate risk/benefit and facilitate drug development decisions.
Experience in developing clinical pharmacology and nonclinical strategy and execute studies such as but not limited to drug-drug interaction studies, specific population, BA/BE, and food effect.
Provides clinical pharmacology support and leadership in preparation of various regulatory documents including study protocol, CSR, Investigator's Brochure, Clinical Pharmacology section of INDs, CTAs, BLAs and/or NDAs, and clinical pharmacology section of package inserts.
Participate in meetings with regulatory agencies and respond to regulatory queries.
Job Requirements
Ph.D. in Pharmacokinetics, Pharmaceutical Sciences, or a closely related discipline with 5+ years of experience for Associate Director or 8+ years of experience for Director in clinical pharmacology, modeling & simulation, drug metabolism and/or pharmacokinetics within a large pharma and / or biotech companies
Experience with nonclinical and clinical pharmacokinetic protocol design with experience working with CRO's is required.
Experience in Model Informed Drug Development.
Strong organizational and time-management skills including the ability to manage several projects simultaneously.
A strong entrepreneurial spirit and a desire to be hands on.
Strong analytical and critical thinking skills, and attention to details.
Demonstrated creativity in problem solving.
Ability to effectively collaborate as part of cross-functional teams and with research partners.
Excellent professional interpersonal skills, particularly oral and written communication skills and be able to work in a multidisciplinary team environment.
Extensive knowledge of regulatory/guidance requirements (i.e. GLP, FDA, EMA) best practices pharmacokinetic/pharmacodynamic testing and risk assessment based on target indication.
The base range for an Associate Director is $182,000- $202,509 and a Director is $220,000 - $253,758 per year. Individual pay may vary based on additional factors, including, and without limitation, job-related skills, experience, work location, and relevant education or training. Kura's compensation package also includes generous benefits, equity, and participation in an annual target bonus.
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Email Alert for Associate Director/Director, Clinical Pharmacology jobs in Boston, MA, United States
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